FDA 510(k) Application Details - K982928

Device Classification Name	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph   More FDA Info for this Device
510(K) Number	K982928
Device Name	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Applicant	RADIOMETER AMERICA, INC. 810 SHARON DR. WESTLAKE, OH 44145-1598 US Other 510(k) Applications for this Company
Contact	VINCE SIGMUND Other 510(k) Applications for this Contact
Regulation Number	862.1120   More FDA Info for this Regulation Number
Classification Product Code	CHL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/20/1998
Decision Date	01/06/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review